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Medical Device Software Systems

MasterControl offers the utopian solution for medical device manufacturers: an end-to-end software solution that enables companies to get their products to market faster while simultaneously maintaining regulatory compliance. By utilizing the MasterControl medical device solution, cross-functional teams can efficiently collaborate on critical documents and processes and accelerate the development cycle.

Who Benefits from MasterControl Medical Device Software System?

Product Development and Engineering: MasterControl readily manages the continual flood of product spec iterations and keeps manufacturing, purchasing, document control, and the supply chain up to date. MasterControl also allows design engineers to work in the CAD environments where they are most comfortable while at the same time helping them to remain in compliance without hampering the development cycle.

Manufacturing/Operations: With MasterControl, manufacturing and operations personnel are connected to the development process earlier and they are able to provide input that will reduce manufacturing costs and get the supply chain lined up sooner. MasterControl insures that documentation used in the manufacturing process is always up to date and robust training management tools affirm that operator training records are current.

Quality: MasterControl helps quality professionals avoid common QMS pains such as CAPA, complaints, and audits and provides more insight into the development process and resulting documentation. Quality professionals can use MasterControl to track and trend quality metrics using the system's built-in analytics tools and scheduled reports. In addition, MasterControl can be utilized to leverage the quality feedback loop in order to improve product design and reduce failures in the field.

Purchasing: MasterControl provides purchasing departments with a single source for product specifications and approved vendor information. Managers can see changes in processes and use the system to enhance efficiency and prevent rework and scrapped product. MasterControl provides the assurance that purchasing decisions will always be based on accurate and up-to-date data.

Regulatory: MasterControl provides regulatory professionals with the means to easily collaborate with the cross-functional development team to assemble documentation for submissions to regulatory bodies such as the FDA. Furthermore, correspondence with regulatory agencies may be stored and tracked in MasterControl, thus providing a single access point for all regulatory information.

Features and Benefits of the MasterControl Software

Accelerate Time to Market:

Medical device companies can launch their products to market faster by using MasterControl to enable the entire development team to execute and communicate their tasks more efficiently using the tools with which they are already familiar and proficient. Some of the benefits that MasterControl offers that can help get medical devices to market faster include:

A Web-based system that involves manufacturing, marketing, quality, and regulatory personnel early in the development cycle to maximize the likelihood of product success.

Makes Efficiency and Compliance Synonymous:

MasterControl offers out-of-the-box, best practices configuration for compliance to standards such as 21 CFR Part 820 and ISO 13485. Design engineers can remain in their native CAD environments and still share vital product specifications with the rest of the organization. By providing electronic workflows and instant access to supporting documentation, MasterControl also reduces the overall cost of MRB.

MasterControl seamlessly integrates with the tools you use every day: CAD, Outlook, Word, MS Project, etc.

Advantages of MasterControl Medical Device Software System

MasterControl's advanced document control functionality is more conducive to streamlining processes throughout the enterprise. Users from any department can easily collaborate on the same document using the applications with which they are most comfortable. The system streamlines supply chain management to help prevent receiving delays, product rework, and scrapping of product. MasterControl also provides an overview of the development pipeline, ensuring that purchasing decisions are based on accurate data. By reducing bottlenecks and inefficiencies across multiple departments, MasterControl reduces the total amount of time it takes to get your product to market while simultaneously enhancing product quality and regulatory compliance.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.